CN104114202A - Drug eluting insert for implantable body - Google Patents

Abstract

The present application discloses embodiments relating to implants and methods of forming implants configured to treat fractured bones. The implant (10) can include a body (20) having a proximal end, a distal end, and an outer surface (28) extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and a high-tensile strength strand (60) positioned adjacent to the body such that at least a portion of the strand extends at least partially along the outer surface of the body in a direction substantially parallel to the central axis, and wherein the strand is loaded with an active agent.

Description

Drug Eluting Inserts for Implantable Subjects

Cross references to related patent applications

This patent application claims the benefit of US Provisional Patent Application 61/599,568, filed February 16, 2012, which is hereby incorporated by reference in its entirety.

technical field

This disclosure generally relates to orthopedics. More specifically, the present disclosure relates to systems and methods for treating fractured bone.

Background technique

Orthopedic implant-associated infection is a potentially serious complication of orthopedic trauma surgery, which often requires long-term systemic antibiotic therapy, reoperation, and hardware removal. There is always a risk of infection following any surgical procedure in which the protective barrier of the skin is breached, however when permanent surgical implants such as intramedullary nails or bone plates remain in the body, the generation of contaminating bacteria necessary for infection volume was significantly reduced. The development of systems and methods for local delivery of antibiotics in conjunction with implants, such as intramedullary nails, could significantly improve therapeutic outcomes involving orthopedic trauma procedures where the drug delivery mechanism is not permanently attached to the implant, And can be applied at the time of surgery to a variety of different implants of different sizes and in different anatomical locations.

Contents of the invention

Various embodiments of implants configured to treat fractured bone are disclosed. In one embodiment, the implant includes a body having a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and a high tension strand , the high tension strand is positioned adjacent to the body such that at least a portion of the strand extends at least partially along an outer surface of the body in a direction substantially parallel to the central axis, and wherein the strand is loaded with an active agent.

In another embodiment, the implant includes a body having a proximal end and a distal end, wherein the body defines a central axis extending from the proximal end to the distal end; the distal end attached to the body when the body is implanted a cap; and a high tension strand received by the cap, wherein the strand is loaded with an active agent.

In another embodiment, the implant includes an intramedullary nail having a proximal end, a distal end, an outer surface extending from the proximal end to the distal end, and an inner surface defining a tract that is in contact with the The central axis extends coaxially along at least a portion of the implant, and a high tension strand positioned adjacent to the staple such that the strand is at least partially disposed within the tract and at least partially along the outer surface of the staple extended, and wherein the strands are loaded with an active agent.

In another embodiment, an implant includes a bone plate and high tension strands. The bone plate includes an outer surface including, for example, a bottom surface and an opposing top surface; a distal end, an opposing proximal end, and a central axis extending from the distal end to the proximal end; The end extends to a proximal body that also extends from the bottom surface to the top surface in a direction perpendicular to the central axis. The high tension strand is loaded with an active agent and positioned adjacent to the bone plate such that the strand is positioned at least partially adjacent the outer surface such that the strand extends along the outer surface in a direction substantially parallel to the central axis.

Methods of forming implants with active agents are also disclosed. For example, in one embodiment, the method includes the step of attaching a high tension strand comprising an active agent to an implantable body, wherein the implantable body has a proximal end and a distal end, extending from the proximal end to the distal end and wherein the body defines a central axis extending from the proximal end to the distal end, and wherein at least a portion of the attached strand extends along a portion of the outer surface of the body in a direction substantially parallel to the central axis.

In another embodiment, a method of forming an implant having an active agent includes the step of attaching a high tension strand comprising an active agent to an implantable body having a proximal end, a distal end, and a central axis extending from the proximal end to the distal end, wherein the body includes a cap attached to the distal end of the body when the body is implanted, and wherein the strands are attached Connect to top cover.

A system configured to form an implant with an active agent is also disclosed. In one embodiment, the system includes an implantable body having a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis of the distal end, the strand retention mechanism includes a cap and a ring, wherein the cap is attached to the distal end of the body when the strand retention mechanism is implanted and the ring is removably secured to the outer surface of the body , and wherein the loop is slidable along the outer surface of the body from distal to proximal, and a plurality of high tension strands are configured to be attached to the cap and removably secured to the loop, wherein the plurality of strands At least a portion of each extends along a portion of the outer surface of the body in a direction from the cap to the ring, and wherein the strands are loaded with the active agent.

Description of drawings

The above summary of the invention and the following specific implementation of the application will be better understood by reading in conjunction with the accompanying drawings. To illustrate the surgical instruments and methods of the present application, preferred embodiments are shown in the drawings. It is to be understood, however, that the application is not to be limited to the specific embodiments and methods disclosed, for which reference is made to the claims. In the attached picture:

Figure 1A is a side view of a fractured bone;

1B is a side view of the implant inserted into the fractured bone shown in FIG. 1A, the implant including a main body, strands, and a strand retention mechanism;

2A is a side elevational view of the main body of the implant shown in FIG. 1B;

Figure 2B is a front view of the main body of the implant shown in Figure 1B;

3A is a perspective view of the strand and strand retention mechanism shown in FIG. 1B, the strand retention mechanism including a cap and a ring member;

Figure 3B is a side elevational view of a top cover according to another embodiment;

Figure 3C is a side elevational view of the top cover shown in Figure 3A;

Figure 3D is a front view of the ring member shown in Figure 3A, according to one embodiment;

3E is a front view of the ring member shown in FIG. 3A according to another embodiment;

3F is a front view of the ring member shown in FIG. 3A according to another embodiment;

Figure 4A is a cross-sectional view of the body and strands shown in Figure 1B;

4B is a cross-sectional view of the body and strands shown in FIG. 1B according to another embodiment;

4C is a cross-sectional view of the body and strand shown in FIG. 1B , and an insertion tool, according to one embodiment;

Figure 4D is a cross-sectional view of the body and strand shown in Figure 1B, and an insertion tool, according to another embodiment;

Figure 4E is a cross-sectional view of the body and strand shown in Figure 1B, and an insertion tool, according to another embodiment;

4F is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B , according to one embodiment;

4G is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4H is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4I is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4J is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4K is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4L is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

4M is a cross-sectional view of the body, strands, and strand retention mechanism shown in FIG. 1B according to another embodiment;

Figure 5 A is a side elevational view of the implant shown in Figure 1 B in an unassembled configuration;

Figure 5B is a side elevational view of the implant shown in Figure 1B in an assembled configuration;

Figure 6A is a side elevational view of a step of inserting the implant shown in Figure 1B into bone;

Figure 6B is a side elevational view of another step of inserting the implant shown in Figure 1B into the bone;

6C is a side elevational view of another step of inserting the implant shown in FIG. 1B into the bone;

Figure 6D is a side elevational view of another step of inserting the implant shown in Figure 1 B into the bone;

7A is a front cross-sectional view of the strand shown in FIG. 1B according to one embodiment;

7B is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7C is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7D is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7E is a side cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7F is a side cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7G is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7H is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

71 is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7J is a side cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7K is a side cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

7L is a front cross-sectional view of the strand shown in FIG. 1B according to another embodiment;

Figure 8A is a bottom plan view of a strand secured to a bone plate, according to one embodiment;

Figure 8B is a bottom plan view of a strand secured to the bone plate shown in Figure 8A according to another embodiment;

Figure 8C is a cross-sectional view of a strand secured to the bone plate shown in Figure 8B;

8D is a bottom plan view of a strand secured to the bone plate shown in FIG. 8A according to another embodiment.

Detailed ways

Certain terms are used in the following description for convenience only and are not limiting. The words "distal" and "proximal" refer to directions toward and away from the patient's body, respectively. The terms "front", "rear", "right", "left", "lower", and "upper" designate directions in the drawings and are hereby used by reference. The terms "anterior", "rear", "upper", "lower", and related words and/or phrases designate exemplary positions and orientations in the human body, by way of reference and not limitation. The terms include the words listed above, their derivatives, and words with similar meanings. Additionally, a three-dimensional coordinate system is used to describe the position and orientation of parts of the implant. The coordinate system includes a longitudinal direction L, a lateral direction A, and a transverse direction T, wherein each of the directions is perpendicular to the other two directions.

As used herein, the term "plurality" means more than one. When expressing a range of values, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed above by use of "about" as approximations, it will be understood that the particular value of the value forms yet another embodiment. Further, when referring to values stated in a range, every value within that range is included. All ranges can be included and combined. Certain features of the invention that are described herein in the context of separate embodiments can also be provided in combination in a single embodiment. Conversely, various features of the invention that are described in the context of a single embodiment can also be provided separately or in any subcombination.

Referring to FIGS. 1A and 1B , a fractured bone 1 includes a fractured part 3 and a medullary cavity 2 located in the main axis of the bone 1 . Fractured bone 1 can be treated by inserting implant 10 into bone 1 . Implant 10 may be configured to facilitate insertion and positioning within medullary cavity 2 of bone 1 . The implant 10 can include a body 20 , a strand 60 , and a strand retention mechanism 70 that secures the strand 60 relative to the body 20 . The body 20 may be elongated in a longitudinal direction L extending from a distal end 22 to a proximal end 24 along a central axis 26 .

The strand 60 is configured to be fixed relative to the body 20, and the strand 60 may be loaded with an active agent. In one embodiment, the strands 60 may be sutures, thread, or any other suitable thread-like material. In another embodiment, the strands 60 may be strips of thin gauge material, such as strips cut from extruded film, or woven or braided textiles having a flat geometry. In one embodiment, the active agent may be an antibiotic such as, for example, gentamicin, which should be suitably selected to reduce or prevent the chance of infection at the implantation site of the implant 20 . The strand retention mechanism 70 is attachable to the body 20 and is configured to secure the strand 60 relative to the body 20 so as to distribute the active agent around the implant 10 as desired.

During use, the distal end 22 of the body 20 can be inserted into the medullary cavity 2 of the fractured bone 1, and the body 20 can then be advanced in the medullary cavity 2 until the distal end 22 is positioned on one side of the fracture 3 and the proximal end 24 Positioned on the other side of the fracture 3, thereby providing fixation to the fractured bone 1 as it heals. The use of implant 10 in the treatment of fractured bone 1 will be described in more detail below.

Referring to FIGS. 2A and 2B , body 20 has a length measured along central axis 26 from distal end 22 to proximal end 24 . The body may also include an outer surface 28 extending from the distal end 22 to the proximal end 24 . Outer surface 28 may define an outer diameter D1 of body 20 . The outer diameter D1 of the body 20 can be varied such that the implant 10 can be selected with a body 20 of the appropriate size outer diameter D1 to treat a particular fractured bone. For example, the outer diameter D1 of the main body 20 for treating a fractured femur may be greater than the outer diameter D1 of the main body 20 for treating a broken rib. In one embodiment, the outer surface 28 of the body 20 may be circular, as shown. Alternatively, outer surface 28 may be tubular or any other shape configured for slidable insertion into the medullary canal of a bone.

The body 20 may also include an inner surface 30 that defines a conduit (or groove) 32 that extends through at least a portion of the length of the body 20 such that, for example, a passageway passes through the opening of the body 20 from the distal end 22 to the proximal end 24. The interior is open. Inner surface 30 may also define an inner diameter D2. In one embodiment, as shown, the inner surface 30 may be circular such that the cross-section of the duct is circular. Alternatively, the inner surface 28 may be any other shape provided that an open passage through the interior of the body 20 is provided.

In one embodiment, the body 20 may also include a first portion 34 and a second portion 36 directly connected to the first portion 34 . The first portion 34 includes the distal end 22 and the second portion 36 includes the proximal end 24 . As shown, the first portion 34 may be aligned parallel to the longitudinal direction L and the second portion 36 may be angularly offset (angle α) from the first portion 34 relative to the longitudinal direction L such that the body 20 is curved. Angle α may vary from about 0° (such that body 20 is not curved) to about 45°. Specifically, in one embodiment, angle α may be about 10°. The body 20 may include a radius at the bend such that the body 20 passes smoothly through the bend. The body 20 may be selected to have an appropriate angle α to facilitate insertion of the body 20 and also to align the fractured bone 1 when the body 20 has been placed in the medullary cavity 2 . The entry site for some intramedullary nails is drilled at an angle to avoid articular surfaces or ligaments, the angle a may be selected to correspond to the entry site.

The body 20 may also define one or more apertures, such as, for example, a locking aperture 38 . Each of the one or more locking apertures 38 extends through the body 20 in a direction substantially perpendicular to the central axis 26 . The locking holes 38 may be of various shapes and sizes, such that the locking holes 38 are configured to receive locking members or fasteners such as, for example, nails or screws. Once the body 20 has been positioned within the fractured bone 1, the locking holes 38 may each receive a locking member to secure the position of the body 20 relative to the fractured bone. As shown, the locking apertures 38 may be provided at various locations along the length of the main body 20 . One or more locking holes 38 may be positioned in the distal end 22 and one or more locking holes 38 may be positioned in the proximal end 24 .

Referring to FIGS. 3A-3D , the strand retention mechanism 70 is configured to secure the strand 60 relative to the body 20 during insertion of the implant 10 into the fractured bone 1 . The strand retention mechanism 70 may include a cap or insert 72 (hereinafter cap) configured to attach to the distal end 22 of the body 20 , and a ring member 82 configured to be received by the outer surface 28 of the body 20 . In one embodiment, ring member 82 may be a full ring, or alternatively, ring member 82 may be a partial ring (eg, C-shaped or U-shaped). Cap 72 may be attached to distal end 22 of body 20 in various ways based on its configuration. For example, in one embodiment, the cap 72 may be disposed at least partially within the conduit 32 of the main body 20 . In another embodiment, the cap 72 may fit over the outer surface 28 of the distal end 22 of the body 20, eg, similar to a sleeve. In yet another embodiment, the cap 72 may be attached to the distal end 22 of the body 20 by utilizing an adhesive. Reference numeral 72 is used throughout this disclosure to generally refer to the cap or insert. Specific embodiments of the top cover 72 are described below, and each embodiment is identified by an increment of 100 (172, 272, 372, etc.). Any description of the general cap 72 may be combined with any of the specific embodiments of the cap 172, 272, 372, and so on.

Referring to FIG. 3B , the top cover 172 as shown includes a shaft 174 and a head 176 coupled directly to the shaft 174 . Shaft 174 defines an outer diameter D3 configured such that shaft 174 is receivable within conduit 32 of body 20 . The head 176 may be the leading edge of the implant 10 when the implant 10 is inserted into the medullary cavity 2 of the fractured bone 1 when the cap 172 has been received within the body 20 as described above. Thus, in one embodiment, the head 176 may be dome-shaped to facilitate insertion of the implant 10 into the bone 1 . In one embodiment, the head 176 defines an outer diameter D4 that is greater than the inner diameter D2 of the conduit 32 such that the head 176 of the cap will not fit completely within the conduit 32 . In addition, it is preferred that the head 176 has sufficient mechanical strength to withstand the forces experienced by the implant 10 during insertion into the fractured bone 1, which implant 10 may typically require repeated blows with a hammer. Although the cap 172 has been described above as including the shaft 174 and the head 176, in another embodiment, the cap 172 can comprise any shape such that the cap 172 is configured to be partially received in the conduit 32 of the body 20. Inside and fixed relative to the main body 20. For example, the cap 172 may be cylindrical, wedge-shaped, cork-shaped, or plug-shaped.

Cap 172 may also include at least one strand securing element 178 configured to secure strand 60 relative to cap 172 such that when distal end 22 and attached cap 172 are advanced into fracture When inside the medullary cavity 2 of the bone 1 , the strand 60 is also advanced into the bone 1 . In one embodiment, the strand securing element 178 may be a bore through which the strand 60 passes. In another embodiment, the strand securing element 178 may include a groove that crimps closed once the strand has been positioned within the groove. In another embodiment, the strand securing elements 178 may be notches or hooks that receive and secure the strands 60 . The strand fixation element 178 is positionable within the shaft 174 (for the strand 60 to be disposed within the conduit 32 of the body 20), within the head 176 (for to be disposed on the outside of the body 20 and adjacent to the main body 20). The strands 60 of the outer surface 28 of the outer surface 28), or may be positioned within both. In another embodiment, the strands 60 are insert molded into the injection molded cap 172 or attached with an adhesive.

Referring to FIG. 3C , in another embodiment, the strand retention mechanism 70 may include a cap 272 . The top cover 272 defines a front end surface 274 , a rear end surface 276 , and a body 278 extending from the front end surface 274 to the rear end surface 276 . As shown in the illustrated embodiment, the body 278 may have a plug-like or cork-like shape. Cap 272 also defines an outer diameter D3 near rear end surface 276 that is less than inner diameter D2 of conduit 32 such that cap 272 is at least partially receivable within conduit 32 of body 20 . In one embodiment, cap 272 also defines an outer diameter D4 near front end surface 274 that is greater than inner diameter D2 of conduit 32 such that cap 272 does not fully fit within conduit 32 . Front end surface 274 may include one or more strand securing elements 78 configured to secure one or more strands 60 relative to cap 272 (see, eg, FIG. 3B ). In another embodiment, the strands 60 may be secured to the front end surface 274 , such as by adhesive, such that no strand securing elements are required on the cap 272 .

Caps 172 and 272 shown in FIGS. 3B and 3C are each configured to be disposed at least partially within conduit 32 of body 20 . However, other embodiments of the top cover 72 are contemplated. In another embodiment, the top cover 72 may be configured such that the entire top cover 72 fits within the conduit 32 of the main body 20 . Such positioning of the cap 72 reduces the likelihood of damage to the cap 72 during insertion of the implant 10 . In another embodiment, the top cover 72 may be configured such that the entire top cover 72 is disposed outside the duct 32 of the main body 20 . As will be described in more detail below with reference to FIG. 4C , cap 372 may be a sleeve-like shape configured to fit over outer surface 28 of distal end 22 of body 20 . The various embodiments of the top cover 72 may be constructed of suitable materials selected based on the intended use of the top cover 72 . For example, the cap 72 may be made of a biodegradable or bioabsorbable material such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polymethylene carbonate (PMC ), polyethylene glycol (PEG), or copolymers of these substances. A biodegradable or bioabsorbable material may be beneficial if it is desired not to remove the cap 72 after insertion. In another embodiment, the top cover 72 may be made of a non-biodegradable or non-bioabsorbable material such as polyethylene, high-density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene , polyetheretherketone (PEEK), nylon, acrylic, or polyurethane. Cap 72 may also be loaded with active agent by any of the methods described throughout this disclosure.

Referring to FIGS. 3A and 3D-3F , ring member 82 may include a front surface 83 , an opposing rear surface 84 , and a length defined as the distance from front surface 83 to rear surface 84 . The ring member may also have an inner surface 85 defining a bore 86 extending through the ring member 82 , which may be centered on a central axis 87 as shown. Bore 86 has a complementary size and shape to outer surface 28 of body 20 such that ring member 82 can slide along outer surface 28 of body 20 when central axis 87 of the bore is aligned with central axis 26 of body 20 . In one embodiment, the bore 86 may be a circle having an inner diameter D5, as shown. The inner diameter D5 is slightly larger than the outer diameter D1 of the main body 20 . The ring member 82 may also include an outer surface 88 that defines an outer diameter D6 of the ring member 82 . Outer diameter D6 is greater than inner diameter D5 such that a thickness is defined between inner surface 85 and outer surface 88 as measured in a direction from inner surface 85 to outer surface 88 and perpendicular to central axis 87 .

The ring member 82 may additionally include one or more strand fixation elements 90 configured to align the one or more strands 60 relative to the direction of the main body 20 during insertion of the implant 10 into the medullary cavity 2 . The outer surface 28 is fixed in a desired orientation. As shown in FIG. 3D , strand securing element 90 includes a groove or notch 92 extending from outer surface 88 to inner surface 85 . Groove 92 may extend the length of loop member 82 to create a passage through a portion of loop member 82 configured to slidably receive strand 60 .

In another embodiment as shown in FIG. 3E , the strand securing element 90 may include a through hole 93 extending from the front surface 83 to the opposite rear surface 84 . Through hole 93 may extend the length of loop member 82 to create a passage through a portion of loop member 82 configured to slidably receive strand 60 . The number and positioning of through holes 93 may be varied as desired to accommodate a particular number of strands 60 and to maintain strands 60 in a desired relative position to one another. For example, the ring member 82 includes one or more (eg, four) through holes 93 spaced evenly around the circumference of the ring member 82 . In another embodiment, the through-holes 93 may be positioned within the ring member 82 such that the through-holes 93 are not evenly spaced from one another.

As shown in FIG. 3F , in another embodiment, the strand securing element 90 includes a flange 94 having a hole 96 . Aperture 96 is configured to slidably receive strand 60 such that strand 60 can translate through aperture 96 . In another embodiment, the strand fixation element 90 may comprise any structure configured to slidably receive the strand 60 and secure the strand 60 relative to the body 20 during insertion of the implant 10 into the bone 1 .

Referring to FIG. 4A , in one embodiment, an implant 10 includes a body 20 and strands 60 . Implant 10 is shown in a ready-to-implant assembled configuration. The strands 60 have been positioned relative to the body 20 such that the strands 60 are disposed partially within the conduit 32 of the body 20 and partially externally of the body 20 adjacent (eg, adjoining) the outer surface 28 . As shown, the strands 60 pass through the conduit 32 at the distal end 22 (the distal end 22 is shown including the locking aperture 38 ) such that the strands 60 are partially disposed within the conduit 32 and partially disposed adjacent the outer surface 28 The exterior of the main body 20. In this embodiment, implant 10 does not include strand retention mechanism 70 . Although the strands 60 are shown passing through the conduit 32 of the body 20 once, in another embodiment, the strands 60 may loop through the conduit 32 around the outer surface 28 of the body 20 more than once and fold back through the conduit. 32, thereby increasing the area of the implant 10 with the active agent thereon.

Referring to Figure 4B, the strands 60 are disposed partially within the conduit 32 of the body 20 and partially externally of the body 20 adjacent the outer surface 28, similar to Figure 4A described above. However, as shown in the illustrated embodiment, the strands 60 pass through the locking aperture 38 to transition from the interior of the conduit 32 to the exterior of the body 20 . In another embodiment, the strand 60 may pass through any hole or hole in the body 20 to position the strand 60 relative to the body 20 as desired. Typically, the strands extend along the outer surface of the body in a direction substantially parallel to the central axis, but the strands may also extend in other directions along the outer surface of the body.

Referring to FIGS. 4C-4E , an insertion tool 196 may be used to thread the strand 60 through the conduit 32 of the body 20 . As shown in FIG. 4C , the insertion tool 196 includes a needle-like body 197 . Needle body 197 may include a front end 198 and an eyelet 199 disposed near front end 198 and configured to receive and retain strand 60 during insertion of strand 60 within conduit 32 of body 20 . During use, the strand 60 is secured within the eye 199 of the needle body 197 . Needle body 197 is then threaded into and through conduit 32 in a direction from proximal end 24 to distal end 22 . Once the strand 60 has passed through the distal end 22, the strand 60 can be removed from the eyelet 199 and the needle body 197 can then be reversed out of the conduit 32 in a direction from the distal end 22 to the proximal end 24.

As shown in FIG. 4D , insertion tool 196 may include a rod-shaped body 297 . Rod body 297 defines a front end 298 and an inner bore 299 . The strand 60 is secured to the front end 298 of the insertion tool 297 and the inner bore 299 encloses at least a portion of the strand 60 during insertion through the conduit 32 . The rod-like body 297 is threaded into and through the conduit 32 in a direction from the proximal end 24 toward the distal end 22 . Once the strand 60 has passed through the distal end 22, the strand 60 can be separated from the front end 298, and then the rod-like body 297 can be reversed out of the conduit 32 in a direction from the distal end 22 toward the proximal end 24, thereby leaving The strands 60 are lowered through the length of the tubing 32 .

As shown in FIG. 4E , insertion tool 196 may include a weight 297 attached to strand 60 . Weight 297 can be any shape that fits within conduit 32 . During use, strand 60 may be attached to weight 297 , for example, by tying strand 60 to weight 297 . Body 20 may be oriented vertically such that proximal end 24 faces upward and away from the ground and distal end 22 faces downward and towards the ground. The weight is then threaded into the conduit 32 at the proximal end 24 and fed to the distal end 22 by gravity. Once the weight 297 and strand 60 have passed through the distal end 22 of the body 20, the weight 297 can be removed from the strand 60. In another embodiment, body 20 may be oriented vertically such that distal end 22 faces upward and away from the ground and proximal end 24 faces downward and towards the ground. A weight is threaded into the conduit 32 at the distal end 24 and is gravity fed to the proximal end 22 .

4F and 4G, in another embodiment, implant 10 includes body 20, strand 60, and strand retention mechanism 70 (including cap 172). Implant 10 is shown in an assembled configuration ready for implantation. The shaft 174 of the cap 172 has been positioned within the conduit 32 at the distal end 22 of the body 20 so as to secure the cap 172 and the body 20 relative to each other. In one embodiment, the strand 60 may be secured to the shaft 174 of the cap 172 such that the strand 60 is positioned completely within the conduit 32 of the main body 20 . In another embodiment, the strand 60 may be secured to the head 176 of the cap 172 such that the entire strand 60 is positioned on the exterior of the conduit 20 and adjacent the outer surface 28 of the body 20 (not shown). In another embodiment, the implant 10 may include a plurality of strands 60 (referred to herein as a first strand 60' and a second strand 60"). One or more first strands 60' may be secured to the shaft 174 of the cap 172 so that the first strand 60' is positioned completely within the conduit 32 of the body 20. Additionally, one or more second strands 60" can be secured to the head 176 of the cap 172 such that the second strand The wire 60" is positioned entirely outside of the conduit 20 and adjacent the outer surface 28 of the body 20. In this embodiment, the strand retention mechanism 70 is not shown to include a ring member 82, although a ring member 82 may be included.

Referring to Fig. 4H, the implant as shown includes a body 20, a strand 60, and a strand retention mechanism 70 (including a cap 372). Implant 10 is shown in an assembled configuration ready for implantation. Cap 372 is configured to fit over outer surface 28 at distal end 22 of body 20 . The cap 372 fits over the outer surface 28 at the distal end 22 of the body 20 (similar to a sleeve) and is positioned entirely outside of the body 20 . The cap 372 may be constructed of an elastic or resilient material such that the cap 372 stretches when fitted over the outer surface 28 at the distal end 22 of the body 20 and the elastic properties of the cap 372 hold the cap 372 relative to the body 20 in place. As shown, the strands 60 are secured to the cap 372 such that each of the strands 60 is positioned entirely outside of the conduit 20 and adjacent the outer surface 28 of the body 20 . In this embodiment, the strand retention mechanism 70 is not shown as including a loop member 82, although a loop member 82 could be included.

Referring to FIG. 41 , in another embodiment, the implant 10 includes a body 20, a strand 60, and a strand retention mechanism 70 (including a cap 172 and a ring member 82). Implant 10 is shown in an assembled configuration ready for implantation. The shaft 174 of the cap 172 has been positioned within the conduit 32 at the distal end 22 of the body 20 so as to secure the cap 172 and the body 20 relative to each other. The main body 20 has been positioned within the ring member 82 such that the inner surface 85 of the ring member 82 slidably contacts the outer surface 28 of the main body 20 . In one embodiment, the strand 60 may be secured to the shaft 174 of the cap 172 such that the strand 60 is positioned completely within the conduit 32 of the main body 20 . In another embodiment, the strand 60 may be secured to the head 176 of the cap 172 such that the entire strand 60 is positioned on the exterior of the conduit 20 and adjacent the outer surface 28 of the body 20 . In another embodiment, the implant 10 may include a plurality of strands 60 (referred to herein as a first strand 60' and a second strand 60"). One or more first strands 60' may be secured to the shaft 174 of the top cap 172 such that the first strand 60' is fully positioned within the conduit 32 of the body 20. Additionally, one or more second strands 60" may be secured to the head 176 of the top cap 172 such that the second strand Wire 60" is positioned entirely outside of conduit 20 and adjacent outer surface 28 of body 20. As shown in the illustrated embodiment, implant 10 includes a first strand 60' and a second strand 60". In another embodiment, the implant 10 may include one or more second strands 60" (disposed on the exterior of the conduit 32) and not include any first strands 60' (disposed on the interior of the conduit 32). In another embodiment, the implant 10 may include one or more first strands 60' (disposed on the inside of the conduit 32) and not include any second strands 60" (disposed on the outside of the conduit 32).

The second strands 60" can be slidably received by the strand securing elements 90 (not shown) of the loop member 82 such that the second strands 60" are maintained in a desired spaced relationship relative to each other. In one embodiment, the spaced relationship may include second strands 60" that are oriented parallel to each other and spaced radially about the outer surface 28 of the body 20. For example, the implant 10 may include strands each spaced about the outer surface 28. Open the four second strands 60" at 90°. Alternatively, the second strands 60" may have non-uniform spacing. In another embodiment, the spacing relationship may include intertwining around the outer surface 28 of the body 20 such that the second strands 60" substantially parallel to each other, or alternatively such that the second strands 60" cross each other.

Referring to FIG. 4J, in another embodiment, implant 10 includes body 20, strand 60, and strand retention mechanism 70 (including cap 272 and ring member 82). As shown in the illustrated embodiment, the top cover 272 may include a longitudinal bore 273 extending through the top cover 272 such that a channel is created in the top cover 272 . During implantation of the implant 10 , K-wires (K-wires) 175 or other guiding mechanisms may be passed through the longitudinal bores 273 to facilitate implantation of the implant 10 . Cap 272 shown in FIGS. 4B-4D may also include a longitudinal bore similar to longitudinal bore 273 configured to receive a Kirschner wire or other guiding mechanism to facilitate implantation of implant 10. enter.

Referring to Figures 4K-4M, another embodiment of an implant 10 includes a body 20, a strand 60, and a strand retention mechanism 70 (including a cap 272 and optional ring member 82). As shown in the illustrated embodiment, the connector 180 with the attached strand 60 may be inserted into the conduit 32 of the main body 20 and secured to the cap 272 . As shown, the top cover 272 includes a connector receiving groove 290 . The connector receiving groove 290 is configured to secure the connector 180 relative to the top cover 272 . The connector 180 defines a front end 182 having a shape, and the connector receiving groove 290 defines a shape corresponding to the shape of the connector 180 . For example, as shown, the front end 182 is rounded or spherical in shape and matches the shape of the connector receiving groove 290 . During use, the cap 272 is secured to the distal end 22 of the body 20 . The connector 180 attached to the insertion tool 196 is then inserted along the conduit 32 of the main body 20 . The insertion tool 196 is advanced toward the distal end 22 until the front end 182 of the connector 180 is received within the corresponding shape of the connector receiving groove 290 . As shown, the front end 182 and the connector receiving groove 290 may have corresponding shapes such that the front end 182 snap fits into the connector receiving groove 290 . The insertion tool 196 may then be withdrawn, thereby leaving the connector 180 secured to the cap 272 and the strand 60 disposed within the conduit 32 of the body 20 . Caps 172 and 372 shown in FIGS. 4F-4I may also include a connector receiving groove similar to connector receiving groove 290 configured to receive a front end of a connector as described above.

Referring to Fig. 5A, implant 10 may comprise an unassembled configuration. The one or more strands 60 include a first end 64 and a second end 66 . The first end 64 of the first strand 60 ′ is attached to the shaft 74 of the cap 72 . The second end 66 of the first strand 60 ′ passes through the bore 86 of the ring member 82 , into the conduit 32 of the body 20 at the distal end 22 , and out through the proximal end 24 . The first end 64 of the second strand 60″ is attached to the head 76 of the top cap 72. The second end 66 of the second strand 60″ passes through the strand securing element 90 of the ring member 82 and is adjacent the outer portion of the main body 20. Surface 28 passes through.

Referring to Fig. 5B, implant 10 may comprise an assembled configuration. The distal end 22 of the body 20 receives the cap 72 and the outer surface 28 receives the ring member 82 . Immediately prior to implantation, loop member 82 may be positioned adjacent distal end 22 and strand 60 may be tensioned and slidably received within strand fixation element 90 of loop member 82 .

Referring to Figures 6A-6D, the method for treating a fractured bone 1 includes inserting an implant 10 into the medullary cavity 2, as described in detail below. As shown in FIG. 6A , the implant 10 is inserted into the medullary cavity 2 at the insertion site 4 such that the cap 72 guides the implant 10 during insertion. A ring member 82 positioned around the outer surface 28 of the body 20 at the distal end 22 contacts the exterior of the bone 1 at the insertion site 4 . The ring member 82 is configured such that it will be adjacent to the outside of the bone 1 at the insertion site 4 , but not into the medullary cavity 2 . As shown in FIG. 6B , the body 20 and cap 72 of the implant 10 have been advanced within the medullary cavity 2 towards the fracture 3 . The ring member 82 remains in its previous position adjoining the exterior of the bone 1 at the insertion site 4 . When the cap 72 and the main body 20 are advanced within the medullary cavity 2 , the strands 60 secured to the cap 72 are also advanced into the medullary cavity 2 . When the strand 60 and the cap 72 are advanced into the medullary cavity 2, the strand 60 slides through the strand retaining element 90 (not shown) of the ring member 82 while retaining it throughout the insertion of the implant 10. required spacing. As shown in FIG. 6C , the implant 10 has been advanced into the medullary cavity 2 so that the main body 20 is partially located on both sides of the fracture 3 . The strands 60 continue to advance with the cap 72 while the loop member 82 maintains the desired spaced relationship of the strands 60 relative to each other. As shown in FIG. 6D , the implant 10 has been fully inserted such that the entire body 20 is positioned within the medullary cavity 2 . The main body 20 is partially located on both sides of the breaking portion 3 . The ring member 82 has been removed so as not to contact the outer surface 28 of the body 20 . The strands 60 may be tied together or knotted and any excess length may be cut off.

During insertion, the cap 72 and strands 60 will be subjected to high shear forces, and thus are preferably configured to withstand those high shear forces. In one embodiment, the body 20 is configured such that the strand 60 contacts the wall 5 defining the medullary cavity 2 and such that the strand 60 is pinched between the wall 5 of the medullary cavity 2 and the outer surface 28 of the body 20 . In other words, the strand 60 that normally contacts or can contact the wall 5 of the medullary cavity 2 during implantation may be positioned on the outer surface 28 of the body 20 . In this embodiment, positioning the strands 60 outside the body 20 will subject the strands 60 to increased shear forces during insertion of the implant 10 (the strands 60 are prepared and configured to withstand said increased shear force). This method of processing allows for a more precise positioning of the strand 60 and thus a more precise delivery of the active agent loaded in the strand 60 .

For example, the strands may be prepared and configured to move or slide relative to the wall 5 of the medullary cavity 2 without damage or degradation during implantation. Thus, in one embodiment, a standard intramedullary nail with a cannula can be used as the main body 20 of the implant, and there is no need to modify the surface of the intramedullary nail to incorporate active agent-loaded strands or in other words protective strands. wire to avoid shear stress. In one embodiment, strands such as bioabsorbable sutures can be axially oriented (drawn) to provide increased tensile strength. Drawn filaments may be coated with a bioabsorbable polymer comprising active agent particles such as gentamicin sulfate by a dip coating process. The active agent particles can be suspended in the polymer or can be dissolved in the coating solution so that the coating is firmly bonded to the surface of the filaments. The filaments and/or coating typically have sufficient strength to be positioned on the outer surface of the intramedullary nail and inserted into the medullary canal of the bone without damaging the suture or stripping the coating.

7A-7L, the individual strands 60 can be loaded with the active agent 62 in a variety of ways such that the strands 60 retain the active agent 62 during implantation of the strands 60 . For example, strands 60 may be sprayed with a solution comprising a drug-polymer-solvent mixture. Additionally, the filaments can be extruded with the drug so that a secondary coating process is not required. Additionally, the filaments can be electrospun.

Active agent 62 can be used to increase the effectiveness of fractured bone therapy by reducing the risk of infection or preventing infection, promoting healing, and the like. Active agents may include particles 63 (eg, gentamicin or other antibiotics, plus growth factors, pain relievers, and anti-inflammatory compounds, for example) and coating 65 . The strand and/or coating material may include additives to render the strand and/or coating material more water permeable or swellable, thereby serving to increase the drug dilution rate of the strand and/or coating material.

The coating may comprise a polymer, such as polyurethane, which may be bioabsorbable or biostable (non-absorbable). Other examples of bioabsorbable polymers may include polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polymethylene carbonate (PMC), polyethylene glycol (PEG), or Copolymers of these substances. Alternatively, the coating may be made of materials other than polymers, such as calcium stearate, magnesium stearate, dextran, collagen, gelatin, polypeptides, proteins, or carbohydrates. In one embodiment, the layer of active agent 62 may have a thickness of about 0.01 mm to about 0.07 mm.

As shown in FIG. 7A, the strand 60 may include a core 68 that is a monofilament. Particles 63 are disposed within coating 65 . Coating 65 surrounds core 68 in layers and is thicker than the diameter of particle 63 . As shown in FIG. 7B, strand 60 may include a core 68 that is monofilament. The particles 63 are distributed throughout the core 68 . Particles 63 may be uniformly distributed or non-uniformly distributed. In this embodiment, active agent 62 may be free of coating 65 . As shown in FIG. 7C, the strand 60 may include a core 68 that is a monofilament. Particles 63 are disposed within coating 65 . Coating 65 surrounds core 68 in layers, and coating 65 is thinner than the diameter of particles 63 so that more particles 63 are exposed.

As shown in Figure 7D, the strand 60 may include a core 68 that is a multifilament. Particles 63 are disposed within coating 65 . Coating 65 surrounds core 68 in layers and is thicker than the diameter of particle 63 . As shown in Figure 7E, the strand 60 may include a core 68 that is a flat strip (or ribbon). In one embodiment, core 68 is made of a polymer material. Particles 63 may be distributed throughout core 68 . Particles 63 may be uniformly distributed or non-uniformly distributed. As shown in Figure 7F, the strand 60 may include a core 68 that is a flat strip (or ribbon). In one embodiment, core 68 is made of a polymer material. The core 68 as shown may be a solid polymer with a coating 65 comprising particles 63 disposed on either side of the core 68 .

As shown in FIG. 7G, the strand 60 may include a core 68 that is a monofilament. Coating 65 surrounds core 68 in layers and coating 65 contains dissolved antibiotic. In this embodiment, active agent 62 may be free of particles 63 . As shown in Figure 7H, the strand 60 may include a core 68 that is a monofilament. Active agent 62 (not shown) includes dissolved antibiotic distributed throughout core 68 . The dissolved antibiotic may be evenly or non-uniformly distributed. In this embodiment, active agent 62 may be free of particles 63 and coating 65 . As shown in Figure 7I, the strand 60 may include a core 68 that is a multifilament. Coating 65 surrounds core 68 in layers and coating 65 contains dissolved antibiotic. In this embodiment, active agent 62 may be free of particles 63 .

As shown in Figure 7J, the strand 60 may include a core 68 that is a flat strip (or ribbon). In one embodiment, core 68 is made of a polymer material. Active agent 62 (not shown) includes dissolved antibiotic distributed throughout core 68 . The dissolved antibiotic may be evenly or non-uniformly distributed. In this embodiment, active agent 62 may be free of particles 63 and coating 65 . As shown in Figure 7K, the strand 60 may include a core 68 that is a flat strip (or ribbon). In one embodiment, core 68 is made of a polymer material. The core 68 as shown may be a solid polymer with a coating 65 comprising dissolved antibiotic disposed on either side of the core 68 . In this embodiment, active agent 62 may be free of particles 63 . As shown in Figure 7L, the strand 60 may include a core 68 that is a monofilament. Particles 63 are disposed within coating 65 . Coating 65 surrounds core 68 in layers and is thinner than the diameter of particle 63 . As shown, the active agent may include, for example, a barrier coating 67 formed from a second polymer layer such that this barrier protects the particles 63 from exposure.

Referring to FIGS. 8A-8D , the implantable body may also include strands 60 that are secured to other types of implants, such as bone plate 500 . Bone plate 500 includes an exterior surface that may include a bottom bone contacting surface 501 , an opposing top surface 503 , and an outer perimeter 513 . Bone plate 500 also includes opposing ends, such as distal end 505 and proximal end 507 . Bone plate 500 also includes a body 509 extending from distal end 505 to proximal end 507 in a direction parallel to central axis 511 such that body 509 defines a length. The body 509 also extends from the bottom surface 501 to the top surface 503 in a direction perpendicular to the central axis 211 such that the body 509 defines a thickness. The body 509 also defines at least one aperture, eg, at least one fastener aperture 502 , 504 , 506 , 508 , 510 extending from the bottom surface 501 to the top surface 503 . Each of the fastener holes 502 is generally configured to receive a bone fastener, such as a non-locking bone screw that secures the bone plate 500 to the underlying bone. The bone plate 500 may include one or more of a non-locking single screw hole 502, a locking and non-locking multiple screw hole 504, a locking multiple screw hole 506, a non-locking multiple screw hole 508, a locking single screw hole 510, or any of them. combination. In general, any of the fastener holes 502, 504, 506, 508, 510 may be used regardless of whether the fastener holes 502, 504, 506, 508, 510 ultimately receive screws or fasteners during application. In another embodiment, instead of using any fastener holes 502, 504, 506, 508, 510, the strands 60 may be secured to either the bottom surface 501 or the top surface 503, such as by utilizing an adhesive. Attached to the bone plate. In other embodiments (not shown), inserts or caps similar to those described herein can be used as a strand retention mechanism and can be configured to fit within or between one or more fastener holes. to anchor the strands to the bone plate.

As shown in FIG. 8A , the strand 60 can be secured to the bone plate 500 by passing the strand 60 through one of the fastener holes 502, 504, 506, 508, 510 and tying a knot in the strand 60 (eg, as shown in the figure). Once the strand 60 has been looped through one of the fastener holes 502 , 504 , 506 , 508 , 510 , the remainder of the strand 60 may be positioned along the bottom surface 501 of the bone plate 500 . Upon insertion, the strand 60 will be positioned between the bone plate 500 and the underlying bone to deliver the active agent loaded on the strand 60 and prevent medical complications. In another embodiment, once the strand 60 has been looped through one of the fastener holes 502, 504, 506, 508, 510, the remainder of the strand 60 can be threaded along the top surface 503 of the bone plate 500. position. Upon insertion, the strand 60 will be positioned between the bone plate 500 and the soft tissue layers to deliver the active agent loaded on the strand 60 and prevent medical complications. In another embodiment, one or more strands 60 may be positioned on both the bottom surface 501 and the top surface 503 . Typically, the strands extend along the outer surface in a direction substantially parallel to the central axis, but the strands may extend in other directions along the outer surface of the body.

As shown in FIGS. 8B and 8C , in another embodiment, the strand 60 may be looped through more than one fastener hole 502 , 504 , 506 , 508 , 510 , for example through two holes. The strands may be looped through the fastener holes one or more times until the desired ratio of active agent-loaded strands 60 to bone plate 500 is achieved.

As shown in FIG. 8D , strands 60 may be attached to bone plate 500 by looping one or more strands 60 through non-fastener holes 512 . Non-fastener holes 512 may be any holes not normally used to receive bone fasteners to secure bone plate 500 to the underlying bone. In one embodiment, non-fastener holes 512 may extend from bottom surface 501 to top surface 503 in a direction perpendicular to central axis 211 such that passage is provided throughout the thickness of bone plate 500 . In another embodiment, non-fastener holes 512 may extend from one of bottom surface 501 or top surface 503 to outer perimeter 513 such that passage is provided in only a portion of the thickness of bone plate 500 .

Those skilled in the art will recognize that modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure, as defined by the following claims.

Claims (54)

1. An implant comprising: a body having a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and a high tension strand positioned adjacent to the body such that at least a portion of the strand is at least partially along the outer surface of the body in a direction substantially parallel to the central axis extended, and wherein the strands are loaded with an active agent. 2. The implant of claim 1, wherein the body includes an inner surface defining a tract, and wherein the tract extends along at least a portion of the implant in a direction coaxial with the central axis , and further wherein said strand is at least partially disposed within said conduit of said body. 3. The implant of claim 2, further comprising a cap at least partially received within the conduit when the body is implanted, wherein the cap is received near the distal end of the body the strands. 4. The implant of claim 3, wherein the cap defines a longitudinal bore configured to receive a guide member to facilitate implantation of the implant. 5. The implant of claim 3, further comprising a ring member including an inner surface defining a bore sized and shaped to slidably receive the outer surface of the body. Surfaces enable translation of the body and ring member relative to each other in a direction substantially parallel to the central axis. 6. The implant of claim 5, wherein the ring member secures the strand relative to the outer surface of the body such that the strand is spaced from at least a portion of the outer surface of the body. 7. The implant according to claim 6, wherein when the main body is implanted in the medullary cavity of the bone, at least a portion of the strand is in contact with both the outer surface of the main body and the bone touch. 8. The implant of claim 1, wherein said body further defines at least one hole extending from said outer surface into said body such that said at least one hole is relative to said center The axis is angularly offset. 9. The implant of claim 8, wherein the strand is at least partially disposed within the hole. 10. The implant of any one of the preceding claims, wherein the strands are biodegradable. 11. The implant of any one of the preceding claims, wherein the strands further comprise a coating. 12. The implant of claim 11, wherein the active agent is disposed as particles within the coating. 13. The implant of claim 11, wherein the active agent is dissolved within the coating. 14. The implant of any one of the preceding claims, wherein the active agent is dissolved within the strand. 15. The implant according to any one of the preceding claims, wherein the active agent is disposed within the strands as particles. 16. The implant of any one of the preceding claims, wherein the strands comprise monofilaments. 17. The implant of any one of the preceding claims, wherein the strands comprise multifilaments. 18. The implant of any one of the preceding claims, wherein the strands comprise at least one band. 19. The implant according to any one of the preceding claims, wherein the active agent comprises at least one antibiotic. 20. The implant of claim 19, wherein the at least one antibiotic comprises gentamicin. 21. The implant of claim 1, wherein the body is configured as a bone plate. 22. The implant of claim 1, wherein the body is configured as an intramedullary nail. 23. An implant comprising: a body having a proximal end and a distal end, wherein the body defines a central axis extending from the proximal end to the distal end; a cap attached to the distal end of the body when the body is implanted; and A high tension strand received by the cap, wherein the strand is loaded with an active agent. 24. The implant of claim 23, wherein the main body includes an inner surface defining a duct, and wherein the duct runs along at least a portion of the main body in a direction coaxial with the central axis from the a proximal end extends to the distal end, and further wherein the cap is disposed at least partially within a conduit of the body such that the strand extends proximally from the cap within at least a portion of the conduit . 25. The implant of claim 23, wherein the body further comprises an outer surface, and at least a portion of the strand extends in a direction substantially parallel to the central axis along a portion of the outer surface . 26. The implant of claim 25, wherein the strands abut an outer surface of the body. 27. The implant of claim 26, further comprising a ring member including an inner surface defining a bore sized and shaped to slidably receive the outer surface of the body. The ring member secures the strand relative to the outer surface of the body such that the strand is spaced apart from the outer surface of the body. 28. The implant of claim 23, wherein at least two active agent loaded high tension strands are attached to the cap. 29. A method of forming an implant with an active agent comprising: attaching a high tension strand comprising an active agent to the implantable body; wherein the implantable body has a proximal end and a distal end, an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and Wherein at least a portion of the attached strand extends along a portion of the outer surface in a direction substantially parallel to the central axis. 30. The method of claim 29, wherein the implantable body further includes an inner surface defining a tract, and wherein the tract runs along the length of the implantable body in a direction coaxial with the central axis. At least a portion extends from the proximal end to the distal end, and further wherein the attached strand is at least partially disposed within the conduit of the body. 31. The method of claim 30, further comprising prior to said attaching step: attaching the strand to an insertion tool; advancing the insertion tool through the tract from the proximal end to the distal end in a direction coaxial with the central axis; and The strand is separated from the insertion tool. 32. The method of claim 29, wherein at least a portion of the strand is attached to the implantable body such that the strand is spaced from the outer surface. 33. A method of forming an implant with an active agent comprising: attaching a high tension strand comprising an active agent to an implantable body, the implantable body having a proximal end, a distal end, and a cord extending from the proximal end to the distal end central axis; wherein the body includes a cap attached to the distal end of the body when the body is implanted, and wherein the strands are attached to the cap. 34. The method of claim 33, wherein the implantable body further includes an inner surface defining a tract, and wherein the tract runs along the length of the implantable body in a direction coaxial with the central axis. At least a portion extends from the proximal end to the distal end, and further wherein the attached strand is at least partially disposed within the conduit of the body. 35. The method of claim 34, further comprising prior to said attaching step: attaching the strand to an insertion tool; advancing the insertion tool through the tract from the proximal end to the distal end in a direction coaxial with the central axis; and The strand is separated from the insertion tool. 36. The method of claim 34, wherein the cap is at least partially disposed within the conduit. 37. The method of claim 36, wherein the cap defines a bore such that when the cap is at least partially disposed within the conduit, the bore is configured to receive a A guide member for implantation of the implant. 38. The method of claim 36, wherein at least a portion of the strand is attached to the implantable body such that the strand is spaced from the outer surface. 39. A drug delivery system comprising: a strand retention mechanism comprising a cap and a ring member, wherein the cap is configured to be attached to the first end of the implantable body and the ring member is configured to be removable firmly fixed to the outer surface of the implantable body such that the ring can slide along the outer surface of the body; and a plurality of high tension strands configured to be attached to the top cap and removably securable to the loop member, wherein the strands are secured to the loop member such that the strands are radially spaced from each other about the ring member, and wherein the strands are loaded with an active agent. 40. The system of claim 39, further comprising an implantable body having a first end, a second end, and an outer surface extending from the first end to the second end , wherein the body defines a central axis extending from the first end to the second end. 41. The system of claim 40, wherein the implantable body further includes an inner surface defining a tract, and wherein the tract runs along the length of the implantable body in a direction coaxial with the central axis. At least a portion extends from the proximal end to the distal end, and further wherein at least one high tension strand is disposed at least partially within the conduit of the body. 42. The system of claim 39, further comprising an insertion tool configured to receive the at least one high tension strand, the insertion tool configured to be advanced within the canal of the implantable body to facilitate the Positioning and attachment of the at least one high tension strand relative to the implantable body. 43. The system of claim 40, wherein the plurality of strands are removably securable to the loop member such that at least a portion of the plurality of strands are spaced from an outer surface of the implantable body. 44. The system of claim 40, wherein the plurality of strands are radially spaced from one another at regular intervals along the outer surface of the body. 45. An implant comprising: An intramedullary nail having a proximal end, a distal end, an outer surface extending from the proximal end to the distal end, and an inner surface defining a conduit coaxial with the central axis extending in a direction along at least a portion of the implant; and a high tension strand positioned adjacent to the staple such that the strand is at least partially disposed within the conduit and extends at least partially along the outer surface of the staple; and wherein said strands are loaded with an active agent. 46. The implant of claim 45, further comprising a cap at least partially received within the conduit when the staple is implanted, wherein the cap is received near the distal end of the main body the strands. 47. The implant of claim 46, wherein the cap defines a bore configured to receive a guide member to facilitate implantation of the implant. 48. The implant of claim 47, further comprising a ring member including an inner surface defining a bore configured to slidably receive an outer surface of the body such that the The body and the ring member are translatable relative to each other. 49. The implant of claim 48, wherein the ring member secures the strand relative to the outer surface of the body such that the strand is spaced from the outer surface of the body. 50. The implant of claim 49, wherein the strands translate distally relative to the ring member as the ring member slides proximally along the outer surface of the body. 51. An implant comprising: bone plate, the bone plate has an outer surface comprising a bottom surface and an opposite top surface; a distal end, an opposing proximal end, and a central axis extending from the distal end to the proximal end; and a body extending from the distal end to the proximal end in a direction parallel to the central axis, the body also extending from the bottom surface to the top surface in a direction perpendicular to the central axis; and a high tension strand loaded with an active agent positioned adjacent to the bone plate such that the strand is at least partially disposed adjacent to the outer surface such that the strand is positioned along the outer surface in extending substantially parallel to the central axis. 52. The implant of claim 51, wherein the bottom surface is a bone contacting surface. 53. The implant of claim 51, wherein the body defines at least one aperture extending from the bottom surface to the top surface, and the strand passes through the at least one aperture. 54. The implant of claim 53, wherein the at least one hole is a bone fastener hole.